Actively Recruiting
Gingival Recession (RT1) Treatment With Different Gingival Augmentation Surgeries Compared With Untreated Contralateral Sites A Randomized Controlled Clinical Study
Led by Misr International University · Updated on 2025-02-11
30
Participants Needed
1
Research Sites
5 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of different gingival augmentation surgeries to treat patients with gingival recession type 1 (RT1), a condition caused mainly by a thin gingival phenotype. This condition may lead to tooth sensitivity, discomfort, and aesthetic concerns. The study aims to compare the outcomes of increasing gingival thickness using either a connective tissue graft or a de-epithelized free gingival graft after non-surgical periodontal cleaning, versus non-surgical cleaning alone. Participants will be randomly assigned to one of three groups: one receiving non-surgical periodontal treatment plus a connective tissue graft using a tunneling technique, another receiving non-surgical treatment plus a partially de-epithelized free gingival graft, and a control group receiving only the non-surgical periodontal treatment. Each group will have an equal number of participants. Follow-up assessments will be made at 3, 6, and 12 months to monitor changes in gingival thickness and other oral health parameters. Throughout the study, participants will undergo clinical assessments including measuring gingival phenotype, recession depth, plaque index, bleeding on probing, and keratinized tissue width at baseline and during follow-ups. Patients will self-report postoperative pain and swelling daily for the first two weeks after surgery. The study includes regular monitoring to ensure proper oral hygiene and uses a masked assessor to evaluate outcomes. Data will be carefully collected and analyzed to determine the effectiveness of the treatments over one year.
CONDITIONS
Brief Title
Gingival Recession (RT1) Treatment With Different Gingival Augmentation Surgeries
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Medically free patients (American Society of Anesthesiologists I; ASA I)
- Patients diagnosed with recession (RT1)
- Fair oral hygiene
- Patient accepting to provide informed consent and follow-up
You will not qualify if you...
- Carious teeth and teeth with periapical infection
- Patients diagnosed with periodontitis
- Smokers
- Pregnant and lactating females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single treatment session with immediate post-surgical care
Participants receive non-surgical periodontal treatment and one of the assigned gingival augmentation surgeries or non-surgical treatment only.
1 treatment visit (in-person) and daily self-assessments for 2 weeks
Duration - 12 months
Participants return for follow-up visits to assess gingival phenotype and other clinical outcomes while ensuring proper oral hygiene.
Visits at baseline, 3, 6, and 12 months (4 visits total)
Trial Site Locations
Total: 1 location
1
Faculty of oral and dental medicine, Misr international university
Cairo, Egypt, 12345
Actively Recruiting
Research Team
Z
Zainab Hafez, Lecturer
S
Shahinaz Al ashiry, Asso. Prof
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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